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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011554
Receipt No. R000012507
Scientific Title Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy
Date of disclosure of the study information 2013/08/22
Last modified on 2015/03/20

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Basic information
Public title Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy
Acronym duloxetine on chemotherapy-induced neuropathy
Scientific Title Effect of duloxetine and vitamin B12 on pain and numbness with chemotherapy-induced neuropathy
Scientific Title:Acronym duloxetine on chemotherapy-induced neuropathy
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We randomize the patients with neuropathy by cancer drugs and administer vitamin B12 and duloxetine or reverse order, and evaluate the symptom reduction by these drugs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes numbness and pain (VAS)
Key secondary outcomes neurological symptoms (CTCAE)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 one week duloxetine 20mg/day (loading dose), three weeks duloxetine 40 mg /day, 2~4 weeks washout period and four weeks vitamin 12 1500mg/day
Interventions/Control_2 reverse order
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
25 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria the patients who were administered vincristine, paclitaxel, docetaxel, bortezomib or oxaliplatine and feel neuropathic pain or numbness (in or outpatients)
Key exclusion criteria 1) bad controlled liver, kidney, heart, lung , hypertension and infectious diseases
2) psychiatric diseases including depression
3) pregnancy or breast-feeding
4) intake MAO inhibitor (contraindication with duloxetine)
5) the cases whom the doctor decide not to be the indication
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Hirayama
Organization Higashi Sapporo Hospital
Division name Department of Hematology/Oncology
Zip code
Address Shiroishiku Higashisapporo 3-3, Sapporo
TEL 011-812-2311
Email hirayama@hsh.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Hirayama
Organization Higashi Sapporo Hospital
Division name Department of Hematology/Oncology
Zip code
Address Shiroishiku Higashisapporo 3-3, Sapporo
TEL 011-812-2311
Homepage URL
Email hirayama@hsh.or.jp

Sponsor
Institute Higashi Sapporo Hospital
Institute
Department

Funding Source
Organization Higashi Sapporo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 07 Month 01 Day
Date analysis concluded
2014 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 22 Day
Last modified on
2015 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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